title: Moral imperialism and multi-centric clinical trials in peripheral countries.
abstract: Moral imperialism is expressed in attempts to impose moral standards from one particular culture, geopolitical region or culture onto other cultures, regions or countries. Examples of Direct Moral Imperialism can be seen in various recurrent events involving multi-centric clinical trials promoted by developed (central) countries in poor and developing (peripheral) countries, particularly projects related to the theory of double standards in research. After the WMA General Assembly refused to change the Helsinki Declaration - which would have given moral recognition to the above mentioned theory - the USA abandoned the declaration and began to promote regional seminars in peripheral countries with the aim of "training" researchers on ethical perspectives that reflect America's best interests. Individuals who received such training became transmitters of these central countries' ideas across the peripheral countries, representing a form of Indirect Moral Imperialism. The paper proposes the establishment of regulatory and social control systems for clinical trials implemented in peripheral countries, through the formulation of ethical norms that reflect the specific contexts of these countries, along with the drawing up and validation of their own national norms.
authors.affiliation: Cátedra UNESCO de Bioética, Universidade de Brasília, Brasília, Brasil. bioetica@unb.br
authors.forename: Volnei
authors.initials: V
authors.lastname: Garrafa
authors.forename: Claudio
authors.initials: C
authors.lastname: Lorenzo
mesh_terms: D001675:Bioethics; D035843:Biomedical Research / Q000941:ethics*; D002986:Clinical Trials as Topic / Q000941:ethics*; D019049:Developed Countries; D003906:Developing Countries; D028781:Ethical Relativism; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006381:Helsinki Declaration; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent; D007391:International Cooperation; D028681:Moral Obligations; D015337:Multicenter Studies as Topic / Q000941:ethics*; D012108:Research Personnel / Q000941:ethics; D014481:United States